Cleared Traditional

K131254 - KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING...

K131254 is an FDA 510(k) clearance for KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING..., manufactured by Kimberly-Clark Corp.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K131254 · Kimberly-Clark Corp. · Anesthesiology device
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Aug 2013
Decision
110d
Days
Class 2
Risk

K131254 is an FDA 510(k) clearance for the KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Roswell, US). The FDA issued a Cleared decision on August 20, 2013 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kimberly-Clark Corp. devices

FDA 510(k) Submission Details - K131254

510(k) Number K131254 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2013
Decision Date August 20, 2013
Days to Decision 110 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 140d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTR Tube, Tracheal (w/wo Connector)

All 131
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K131254.
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K132415 · Teleflexmedical, Inc. · Jun 2014
KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING
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